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Safety of Oil from Schizochytrium Limacinum (Strain FCC-3204) for Use in Infant and Follow-On Formula As a Novel Food Pursuant to Regulation (EU) 2015/2283

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Safety of Oil from Schizochytrium Limacinum (Strain FCC-3204) for Use in Infant and Follow-On Formula As a Novel Food Pursuant to Regulation (EU) 2015/2283 SCIENTIFIC OPINION ADOPTED: 24 November 2020 doi: 10.2903/j.efsa.2021.6344 Safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhauser-Berthold,€ Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Henk van Loveren, Emanuela Turla and Helle Katrine Knutsen Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain FCC- 3204, used by the applicant (Fermentalg), belongs to the species Schizochytrium limacinum. The NF, an oil rich in docosahexaenoic acid (DHA), is obtained from microalgae after enzymatic lysis. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use. © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: Novel foods, Schizochytrium limacinum, docosahexaenoic acid (DHA), infants and young children, alga, fatty acid, safety Requestor: European Commission Question number: EFSA-Q-2019-00187 Correspondence: [email protected] www.efsa.europa.eu/efsajournal EFSA Journal 2021;19(1):6344 Safety of oil from Schizochytrium limacinum (strain FCC-3204) – IF and FOF Panel members: Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch- Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti. Suggested citation: EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold€ M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Turla E and Knutsen HK, 2021. Scientific Opinion on the safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2021;19(1):6344, 19 pp. https://doi.org/10.2903/j.efsa. 2021.6344 ISSN: 1831-4732 © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2021;19(1):6344 Safety of oil from Schizochytrium limacinum (strain FCC-3204) – IF and FOF Table of contents Abstract................................................................................................................................................... 1 1. Introduction................................................................................................................................. 4 1.1. Background and Terms of Reference as provided by the requestor................................................... 4 1.2. Information on existing evaluations and authorisations.................................................................... 4 2. Data and methodologies ............................................................................................................... 4 2.1. Data............................................................................................................................................ 4 2.2. Methodologies.............................................................................................................................. 5 3. Assessment.................................................................................................................................. 5 3.1. Introduction................................................................................................................................. 5 3.2. Identity of the NF......................................................................................................................... 5 3.3. Production process ....................................................................................................................... 6 3.4. Compositional data....................................................................................................................... 6 3.4.1. Stability ....................................................................................................................................... 10 3.5. Specifications ............................................................................................................................... 11 3.6. History of use of the NF and/or of its source .................................................................................. 12 3.6.1. History of use of the source .......................................................................................................... 12 3.6.2. History of use of the NF................................................................................................................ 13 3.7. Proposed uses and use levels and anticipated intake....................................................................... 14 3.7.1. Target population ......................................................................................................................... 14 3.7.2. Proposed uses and use levels ........................................................................................................ 14 3.7.3. Anticipated intake of the NF.......................................................................................................... 15 3.8. Absorption, distribution, metabolism and excretion (ADME) ............................................................. 15 3.9. Nutritional information .................................................................................................................. 15 3.10. Toxicological information............................................................................................................... 16 3.10.1. Qualified presumption of safety (QPS)............................................................................................ 16 3.10.2. Absence of marine biotoxins.......................................................................................................... 16 3.10.3. Toxicity of DHA-oils derived from Schizochytrium sp........................................................................ 16 3.10.4. Summary..................................................................................................................................... 16 3.11. Allergenicity ................................................................................................................................. 17 4. Discussion ................................................................................................................................... 17 5. Conclusions.................................................................................................................................. 17 6. Steps taken by EFSA .................................................................................................................... 17 References............................................................................................................................................... 17 Abbreviations ........................................................................................................................................... 19 www.efsa.europa.eu/efsajournal 3 EFSA Journal 2021;19(1):6344 Safety of oil from Schizochytrium limacinum (strain FCC-3204) – IF and FOF 1. Introduction 1.1. Background and Terms of Reference as provided by
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